【摘要】 目的:了解四川省老年患者(≥65岁)药品不良反应(ADR)报告的现状及特点,为保障其用药安全提供参考。方法:调取2013-2019年四川省ADR监测中心自发呈报系统收集的老年患者ADR报告数据,对报告类型、上报机构、关联性及患者年龄、性别、民族、药物类型、累及器官/系统等情况进行统计分析。结果与结论:7年间,四川省ADR监测中心收集的自发ADR报告共175 431例。"一般的"ADR报告的年占比从2013年的78.93%逐年下降至60.50%;"新的一般的""严重的"ADR报告年占比逐年上升,其中"新的一般的"ADR上升更明显;主要上报机构是医疗机构,年占比为92.79%～98.87%,企业、个人呈报ADR的积极性有待提高;关联性"肯定"的有8 031例(4.58%),"很可能"的有21 283(12.13%),"可能"的有146 117例(83.29%);除272例ADR未报告性别外,其余ADR涉及男性88 176例、女性86 983例,以65～74岁最多(104 962例,59.83%);报告共涉及19个民族,其中汉族患者166 752例(98.72%),彝族、藏族、羌族老年患者ADR涉及药物的类别分布与汉族显著不同(P<0.01)。上报总频次排名前3位的药物类别为抗感染药(31.10%)、中药(18.27%)、中枢神经系统药物(9.99%)。注射给药途径引发ADR最多(72.12%);ADR主要累及皮肤及其附件(21.47%)、胃肠系统(19.61%)和中枢及外周神经系统(18.55%)。氨茶碱注射液为唯一连续7年进入引发"新的一般的"ADR排名前10位的药品;连续7年均进入引发"严重的"ADR排名前10位的药品有注射用头孢噻肟钠、注射用头孢曲松钠、注射用头孢哌酮钠舒巴坦钠,临床应予以高度重视。更多还原

【Abstract】 OBJECTIVE:To investigate the situation and characteristics of ADR reports in the elderly patients(≥65 years old)of Sichuan province,and to provide reference for guaranteeing the safety of drug use. METHODS:ADR reporting data of elderly patients collected by spontaneous reporting system of Sichuan ADR monitoring center from 2013 to 2019 were collected,and then analyzed in respects of report types,reproting institution,relationship,patienst’age,gender,nationality,drug type,organ/system invovled. RESULTS & CONCLUSIONS:In the past seven years,175 431 cases spontaneous ADR were collected by Sichuan ADR monitoring center,and the annual proportion of"general"ADR reports decreased from 78.93% in 2013 to 60.50% year by year;the annual proportion of"new general"and"serious"ADRs increased year by year,among which that of"new general"ADR increased more obviously. The main reporting institutions were medical institutions,accounting for 92.79%-98.87% of the total annual reports. The enthusiasm of enterprises and individuals to report ADR needed to be improved;8 031 cases(4.58%) were"positive"relationship,21 283 cases(12.13%)were"likely",146 117 cases(83.29%)were"possible". Except that the gender of 272 cases were not reported,there were 88 176 male cases and 86 983 female cases;most of them were 65-74 years old(104962 cases,59.83%). The reports covered 19 nationalities,among which there were 166 752 cases(98.72%)of Han nationality.The distribution of ADR related drug categories in elderly patients of Yi, Tibetan and Qiang nationalities was significantly different from that of Han nationality(P<0.01).The top three drug categories in the total frequency were anti-infective drugs(31.10%),traditional Chinese medicine(18.27%),and central nervous system drugs(9.99%). The injection route was the most likely to cause ADR(72.12%).ADR mainly involved skin and its appendants(21.47%),gastrointestinal system(19.61%)and central and peripheral nervous system(18.55%). Aminophylline injection was the only drug in the top 10 drugs leading to"new general"ADR for consecutive 7 years. Cefotaxime sodium for injection,Ceftriaxone sodium for injection,Cefoperazone sodium and sulbactam sodium for injection were the top 10 drugs causing"severe"ADR in consecutive7 years,which should be paid more attention in clinic.更多还原